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Misoprostol Before and After Cesarean Section

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03463070
Recruitment Status : Unknown
Verified March 2018 by sarah mohamed hassan, Kasr El Aini Hospital.
Recruitment status was:  Not yet recruiting
First Posted : March 13, 2018
Last Update Posted : March 13, 2018
Sponsor:
Information provided by (Responsible Party):
sarah mohamed hassan, Kasr El Aini Hospital

Study Description
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Brief Summary:
comparison of the effect of misoprostol before and after cesarean on the blood loss

Condition or disease Intervention/treatment Phase
Post Partum Hemorrhage Drug: rectal misoprostol 600mg Phase 3

Detailed Description:
70 women who received 600 mg misoprostol rectally preoperatively versus 70 women who received 600 mg misoprostol postoperatively at operating theatre
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: The Effect of Misoprostol Given Preoperative Versus Postoperative on Blood Loss With Elective Cesarean Section: Randomized Controlled Trial
Estimated Study Start Date : March 2018
Estimated Primary Completion Date : September 2018
Estimated Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

Drug Information available for: Misoprostol

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: preoperative misoprostol group
70 women who received 600 mg misoprostol rectally preoperatively before cesarean section
 Drug: rectal misoprostol 600mg
70 women who received 600 mg misoprostol postoperatively at operating theatre
Active Comparator: postoperative misoprostol group
70 women who received 600 mg misoprostol postoperatively at operating theatre after cesarean section
 Drug: rectal misoprostol 600mg
70 women who received 600 mg misoprostol postoperatively at operating theatre


Outcome Measures
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Primary Outcome Measures :
  1. intraoperative blood loss [ Time Frame: the operation time ]
    Difference in weight of linen towels (gm)+Volume of contents of suction bottle (ml)

  2. postoperative blood loss [ Time Frame: every 6 hours during first 24 hours. ]
    weighing the soaked napkins after collection of soaked towel


Eligibility Criteria
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Ages Eligible for Study:   20 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Women not in active labor have reactive non-stress test.
  • No contraindications to prostaglandins.
  • Have no history of coagulopathy.

Exclusion Criteria:

  • Placenta previa.
  • Maternal hypertension.
  • Diabetes mellitus.
  • Previous CS and those with active labor.
  • Multiple Fibroid uterus.
  • Multiple pregnancies or polyhydramnios.
  • Previous myomectomy, previous history of PPH.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03463070


Locations
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Egypt
Kasr El Ainiy Hospital
Cairo, Egypt, 11562
Sponsors and Collaborators
sarah mohamed hassan
More Information
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Responsible Party: sarah mohamed hassan, lecturer of obstetrics and gynecology, Kasr El Aini Hospital
ClinicalTrials.gov Identifier: NCT03463070    
Other Study ID Numbers: 1122345
First Posted: March 13, 2018    Key Record Dates
Last Update Posted: March 13, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by sarah mohamed hassan, Kasr El Aini Hospital:
misoprostol
postpartum haemorrhage
Additional relevant MeSH terms:
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Postpartum Hemorrhage
Hemorrhage
Pathologic Processes
Obstetric Labor Complications
Pregnancy Complications
Puerperal Disorders
Uterine Hemorrhage
Misoprostol
 Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Anti-Ulcer Agents
Gastrointestinal Agents
Oxytocics